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NSAID Use in Postpartum Hypertensive Women

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ClinicalTrials.gov Identifier: NCT02902172
Recruitment Status : Terminated (Unable to recruit necessary number of patients)
First Posted : September 15, 2016
Results First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Goldkamp, MD, St. Louis University

Study Description
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Brief Summary:
Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. Blood pressures during the postpartum period will then be collected and compared in order to see if NSAIDs use increases blood pressure.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Acetaminophen Drug: NSAID Phase 4

Detailed Description:

The patients who have a vaginal delivery and have the diagnosis of hypertension in pregnancy will be randomized to either Ibuprofen use or acetaminophen use during the postpartum period. Standard blood pressure monitoring in the postpartum period will be followed to help determine if there is a significant rise in the women who use NSAIDS in the postpartum period versus those that use acetaminophen.

Groups will be divided into women with chronic hypertension, women with chronic hypertension with superimposed preeclampsia, women with preeclampsia without severe features, women with preeclampsia with severe features, women with gestational hypertension without severe range blood pressures, and women with gestational hypertension with severe range blood pressures.

Recruitment will last 36 months. Patients will be monitored during their postpartum stay (typical 2 days) with blood pressure measurements. An additional 12 months will be needed for data analysis and publication.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: NSAID Use in Postpartum Hypertensive Women
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : October 8, 2017
Actual Study Completion Date : October 8, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Acetaminophen
Patients will be monitored for change in blood pressure
 Drug: Acetaminophen
Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
Other Name: Tylenol
NSAID
Patients will be monitored during their postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
 Drug: NSAID
Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
Other Name: Ibuprofen


Outcome Measures
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Primary Outcome Measures :
  1. Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. [ Time Frame: 2 days ]
    To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery.


Secondary Outcome Measures :
  1. Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. [ Time Frame: 2 days ]
    To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing diastolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of diastolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of diastolic blood pressures from 24 hours to 47 hours after delivery.


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • vaginal delivery
  • diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
  • preeclampsia without severe features
  • preeclampsia with severe features gestational hypertension without severe range blood pressures
  • gestational hypertension with severe range blood pressures
  • singleton pregnancies

Exclusion Criteria:

  • Cesarean Delivery
  • no diagnosis of hypertensive disorder
  • chronic or acute renal disease
  • allergy to ibuprofen or acetaminophen
  • lupus
  • multiple order pregnancies (twins, triplets)
  • Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902172


Locations
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United States, Missouri
St. Mary's Health Center
Saint Louis, Missouri, United States, 63117
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Jennifer Goldkamp, MD St. Louis University
  Study Documents (Full-Text)

Documents provided by Jennifer Goldkamp, MD, St. Louis University:
Study Protocol and Statistical Analysis Plan  [PDF] June 9, 2017

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jennifer Goldkamp, MD, MD, St. Louis University
ClinicalTrials.gov Identifier: NCT02902172    
Other Study ID Numbers: 26976
First Posted: September 15, 2016    Key Record Dates
Results First Posted: October 31, 2018
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action